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Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis (FILLMORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04741087
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Applied Molecular Transport

Brief Summary:
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Condition or disease Intervention/treatment Phase
Pouchitis Drug: AMT-101 (oral)-Dose A Drug: AMT-101 (oral)-Dose B Phase 2

Detailed Description:
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects With Chronic Antibiotic-resistant Pouchitis
Actual Study Start Date : February 5, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Active Comparator: AMT-101 (Dose A)
Dose A: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose A
AMT-101 is an orally administered biologic therapeutic, taken once daily.

Active Comparator: AMT-101 (Dose B)
Dose B: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose B
AMT-101 is an orally administered biologic therapeutic, taken once daily.




Primary Outcome Measures :
  1. Stool Frequency Response [ Time Frame: 12 weeks ]
  2. Histologic Healing [ Time Frame: 12 weeks ]
    based upon the Geboes scoring system and PDAI


Secondary Outcome Measures :
  1. Histologic Response [ Time Frame: 12 weeks ]
    based upon the Geboes scoring system and PDAI

  2. Change in Endoscopic Score [ Time Frame: 12 weeks ]
  3. Change in Stool Frequency [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Chronic or recurrent pouchitis

Exclusion Criteria:

  • Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
  • History or current evidence of colonic or abdominal abnormalities.
  • Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741087


Contacts
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Contact: AMT Administrator 650-392-0420 FillmoreStudy@appliedmt.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Applied Molecular Transport
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Responsible Party: Applied Molecular Transport
ClinicalTrials.gov Identifier: NCT04741087    
Other Study ID Numbers: AMT-101-201
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Molecular Transport:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases